PCSK9 RNA silencing agent reduces LDL-c in diabetes patients with high CV risk
A subcutaneous injection of 300 mg inclisiran at day 1 and day 90 lowered LDL-c by >50% at day 180 in patients with atherosclerotic CVD (ASCVD), regardless of diabetes status, according to data presented at the American Diabetes Association 78th Scientific Sessions in Orlando, FL, USA. Inclisiran had a similar adverse event profile in patients with and without diabetes with no effects on blood glucose control over 6 months.
ORION-1 is a placebo-controlled, double-blind, randomized phase II trial of single or multiple subcutaneous injections of inclisiran in 501 patients with ASCVD or risk equivalent patients and elevated LDL-c despite maximum tolerated doses of LDL-c lowering therapies. The primary endpoint of the trial was the percentage change in LDL-C from baseline at day 180. Inclisiran is a RNA interference agent, inhibiting the synthesis of PCSK9 in the liver, thereby reducing liver cell LDL-receptor turnover and lowering plasma LDL-c.
Professor Leiter said “Individuals with type 2 diabetes remain at high risk for CVD. These data support the potential of inclisiran as an excellent option to further lower LDL-C in patients with diabetes, given inclisiran’s efficacy, much lower injection frequency and clean safety profile to date.”